Tempo Refill Kit

Primary DI
00300020947553
Brand
Tempo Refill Kit
Company
ELI LILLY AND COMPANY
Model
MS9599
Catalog number
MS9599001AM
Device description
Tempo Refill Kit - Convenience Kit for patients with diabetes, which contains lancets, testing strips, and BD needles.
Published
2022-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
NBWSystem, Test, Blood Glucose, Over The Counter
OCNInsulin Autoantibody Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2
OCNInsulin Autoantibody KitImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212217000Tempo Smart ButtonEli Lilly and Company2022-09-16QOG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30300020947554PackageGS11Not in Commercial Distribution
00300020947553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030002094755430300020947554
00300020947553003000209475533000209475530300020947553

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature34 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-855-545-5983xx@xxx.xxx

Regulatory Flags#

DUNS number
006421325
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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